|
|
|
|
|
FDA Links -- About CDER/FDA News
- FDA issues an FDA Alert and Information
for Healthcare Professional sheet for Mycophenolate Mofetil (marketed as
CellCept) and Mycophenolic Acid (marketed as Myfortic).
Drug Information (5/16/2008)
- Best Pharmaceuticals for Children Act of
2007:
List of Determinations Including Written Request (updated 5/15/2008)
- Aprotinin Injection (marketed as
Trasylol): Manufacturer Removes Remaining Stocks of Trasylol.
FDA News
and
Information (5/14/2008)
-
FDA releases a Follow-up to the November 14, 2007,
Communication about the Ongoing Safety Review of Cefepime (marketed as
Maxipime) (5/14/2008)
-
Medical, Statistical, and Clinical Pharmacology Reviews
of Pediatric Studies (updated 5/14/2008)
- CDER Organization Charts [HTML]
[PDF]
(updated 5/13/2008)
- FDA requests that health
professionals and facilities review and examine all drug/device storage
areas to ensure that all recalled heparin products have been removed and
are no longer available for patient use.
MedWatch Safety Information (5/12/2008)
-
Medical, Statistical, and Clinical Pharmacology Reviews
of Pediatric Studies (updated 5/9/2008)
-
Drug Safety Oversight Board Roster
(updated 5/2/2008)
-
Drug Safety Oversight Board Meeting, March 20, 2008
Public Summary (5/2/2008)
- The prescribing information for Enbrel (etabercept)
is revised to include a boxed warning about infections.
MedWatch Safety Information (5/2/2008)
-
FDA approves Amitiza (lubiprostone) for the treatment of
irritable bowel syndrome with constipation in adult women aged 18 and
over
(4/30/2008)
-
Actavis Totowa LLC recalls all strengths of Digitek (digoxin
tablets, USP), a drug used to treat heart failure and abnormal heart
rhythms (4/29/2008)
-
Medical, Statistical, and Clinical Pharmacology Reviews
of Pediatric Studies (updated 4/29/2008)
-
FDA updates information to healthcare facilities and
healthcare professionals about heparin and heparin-containing medical
products (4/25/2008)
-
Postmarketing Study Commitments: Introduction
(updated 4/25/2008)
-
FDA approves Relistor (methylnaltrexone
bromide) for opioid-induced constipation (4/25/2008)
- Office of Nonprescription Products:
Rx to OTC
Switch (updated 4/24/2008)
-
FDA approves Cimzia (certolizumab pegol) to treat Crohn's
disease (4/22/2008)
-
Medical, Statistical, and Clinical Pharmacology Reviews
of Pediatric Studies (updated 4/22/2008)
-
CDER issues "Review of Therapeutic
Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg" ( 4/16/2008)
-
Investigational Human Drugs: Clinical Investigator
Inspection List (CLIIL) (updated 4/14/2008)
- Creating New Knowledge:
FDA & Industry in Dialogue, May 6, 2008,
Philadelphia, PA. The seventh conference between the FDA and
industry sponsored by Temple University School of Pharmacy.
Keynote Speaker: Janet Woodcock, M.D., Director, CDER. This
conference provides participants, industry, and the FDA a forum for
dialogue about critical issues affecting drug development.
Agenda and registration
(4/11/08)
-
Bioresearch Monitoring Information System (BMIS)
(updated
4/10/2008)
-
FDA issues a Communication About an Ongoing Safety Review
of CellCept and Myfortic (4/10/2008)
-
Pfizer informs healthcare professionals and patients of
updated safety information in the labeling for Exubera, a short-acting
insulin (4/10/2008)
-
Schwarz Pharma recalls Neupro, a transdermal delivery
system used to treat early stage Parkinson’s disease, at the end of
April (4/10/2008)
-
Fast
Track Designation Request Performance Report -
Update (Posted: 4/9/2008)
- Cubist Pharmaceuticals, Inc.
informs healthcare professionals that a potentially significant impurity
has been isolated from reconstituted Cubicin stored in with ReadyMED
elastomeric infusion pumps manufactured by Cardinal Health, Inc.
MedWatch Safety Information (4/9/2008)
-
Research in the Division of Drug Marketing,
Advertising, and Communications (DDMAC) (4/9/2008)
-
FDA release information on adverse events and heparin
(4/8/2008)
-
Impurity Evaluation of Heparin Sodium by 1H-NMR
Spectroscopy (updated
4/8/2008)
-
CDER Key Officials (Updated
4/4/2008)
- GlaxoSmithKline informs healthcare
professionals of changes to the prescribing information for Relenza
regarding information from postmarketing reports.
MedWatch Safety Information (4/2/2008)
-
Novartis will no longer make Zelnorm available under a
treatment IND protocol (4/2/2008)
-
FDA issues a Communication about an Ongoing Safety Review
of Regranex (marketed as Becaplermin) (3/28/2008)
-
FDA issues an Early Communication about an Ongoing Safety
Review of Ziagen (marketed as Abacavir) and Videx (marketed as
Didanosine) (3/28/2008)
-
FDA issues an Early Communication about an Ongoing Safety
Review of Montelukast (marketed as Singulair)
(3/27/2008)
-
FDA releases information on Risk Evaluation and
Mitigation Strategies (REMS)
(3/26/2008)
- On March 21, 2008, B. Braun
Medical Inc. was notified by its supplier, Scientific Protein
Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP
active pharmaceutical ingredient (API).
MedWatch Safety Information (3/24/2008)
-
FDA issues an Early Communication about an Ongoing Safety
Review of Tiotropium (marketed as Spiriva HandiHaler)
(3/18/2008)
- FDA releases its second issue of the
FDA Drug
Safety Newsletter
(3/18/2008)
-
FDA releases a progress report on the New Molecular
Entities (NME) Post-Marketing Safety Evaluation Pilot Program
(3/18/2008)
- Amgen and FDA notify healthcare
professionals of changes to the Boxed Warnings/Warnings for increased
mortality and/or tumor progression section of the Aranesp and Epogen/Procrit
labeling.
MedWatch Information (3/13/2008)
- FDA and Tibotec Therapeutics
notify healthcare professionals of changes to the Warnings section of
the prescribing information for Prezista (darunavir) tablets regarding
the risk of hepatotoxicity.
MedWatch Information
-
FDA updates screening method for heparin: Impurity
Evaluation of Heparin Sodium by 1H-NMR Spectroscopy
(PDF, 3/11/2008)
- FDA issues an Information for
Healthcare Professionals sheet and Public Health Advisory for Tussionex
Pennkinetic Extended-Release Suspension, a long-acting hydrocodone-containing
cough product.
Drug Information (3/11/2008)
-
FDA
releases information on two tests that manufacturers and regulators can
use to screen heparin for contaminants (Posted: 3/6/2008)
-
Cyber Letters (updated
3/5/2008)
-
FDA updates safety information for long acting beta
agonists (LABA). (3/5/2008)
-
FDA issues a
Public Health Advisory highlighting the correct use of Spiriva (tiotropium
bromide inhalation powder) and Foradil (formoterol fumarate inhalation
powder) capsules (2/29/2008)
-
Medical, Statistical, and Clinical Pharmacology Reviews
of Pediatric Studies (updated
2/29/2008)
-
Baxter Healthcare Corporation has voluntarily recalled all of their
multi-dose and single-use vials of heparin sodium for injection, and
their heparin lock flush solutions (2/28/2008)
-
CDER Key Officials (PDF,
2/26/2008)
-
PriCara and Sandoz Inc. recall all lots of 25 mcg/hr
Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches sold
in the United States (updated
2/15/2008)
-
Medical, Statistical, and Clinical
Pharmacology Reviews of Pediatric Studies (2/14/2008)
-
New addresses and phone numbers for PDUFA
correspondence (2/13/2008)
-
FDA
announces that Baxter Healthcare Corp. has temporarily stopped
manufacturing multiple-dose vials of the injectable blood-thinning drug
heparin due to reports of serious allergic reactions and hypotension
(2/11/2008)
-
FDA issues an Early Communication about an
Ongoing Safety Review for Botox and Botox Cosmetic (Botulinum toxin Type
A) and Myobloc (Botulinum toxin Type B) (2/8/2008)
-
FEDERAL REGISTER: Revisions to the Requirements
Applicable to Blood, Blood Components and Source Plasma; Confirmation of
Effective Date and Technical Amendment; Direct Final Rule
(2/8/2008)
-
On February 6, FDA approved the first generic versions of
Fosamax (alendronate sodium tablets), used to treat osteoporosis
(2/7/2008)
-
FDA takes action to stop the marketing of unapproved
injectable drugs containing colchicine
(2/6/2008)
- CDER Organization Charts [HTML]
[PDF]
(updated 2/6/2008)
-
Division of Scientific Investigations, Office of
Compliance: Contact DSI
(updated 2/5/2008)
- Standard Costs for Components of the
Process for the Review of Human Drug Applications [HTML]
[PDF] (2/4/2008)
-
FDA issues a Public Health Advisory and Information for
Healthcare Professional sheet for Chantix (varenicline)
(2/1/2008)
- Office of Nonprescription Products:
Rulemaking History for Nonprescription Products (updated 2/1/2008)
-
FDA issues an FDA Alert and Information for Healthcare
Professional sheet for suicidality and antiepileptic drugs
(Posted 1/31/2008)
- 2nd Annual FDA/DIA
Statistics Forum, Marriott Bethesda,
Bethesda, MD, April 13-16, 2008
Meeting Information (1/30/2008)
-
Clarification of Recent FDA Initiatives Affecting OTC Drugs
(1/25/2008)
- Bayer and FDA inform healthcare professionals of the market withdrawal
of the current liquid formulation of Leukine (sargramostim).
MedWatch Information (1/24/2008)
-
FDA
approves additional changes to the Ortho Evra Contraceptive Transdermal
(Skin) Patch label (1/22/2008)
- FDA issues a Public Health
Advisory recommending that over-the-counter (OTC) cough and cold
products should not be used to treat infants and children less than 2
years.
FDA News |
Public Health Advisory (1/17/2007)
- FDA issues a Federal Register
notice [HTML]
[PDF] to
inform companies that the Direct-to-Consumer (DTC) television
advertisement user fee program will not commence. (1/16/1008)
-
FDA issues a Public Health Advisory on edetate disodium (marketed as
Endrate and generic products) (1/16/1008)
-
Cyber Warning Letters (updated
1/15/2008)
-
FDA approves Tysabri (natalizumab) to treat
moderate-to-severe Crohn's Disease.
(1/15/2008)
-
Bioresearch Monitoring Information System (BMIS) File
(updated 1/11/2008)
-
FDA takes action against compounded menopause hormone
therapy drugs (1/11/2008)
-
Submitting
Electronic Documents to the Office of Generic Drugs (OGD) (1/9/2008)
|
|
